Hsiner Nebulizer Bottle
FDA 510(k) K070948 · Hsiner
510(k) numberK070948
Submission
- Device name
- Hsiner Nebulizer Bottle
- Applicant
- Hsiner
Temecula, CA, US - Received
- April 4, 2007
- Decision date
- April 25, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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| K242354 | AllNEBCAF · Traditional | Enchant Tek Co. , Ltd. | 04/29/2025SE |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterCAF · Special | Thayer Medical Corporation | 06/18/2024SE |
| K232507 | Aerogen®Solo Nebulizer SystemCAF · Traditional | Aerogen, Ltd. | 05/10/2024SE |
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| K251888 | VPAP Pediatric Face MaskCBK · Traditional | 03/12/2026SE |
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| K102120 | Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model…CBK · Traditional | 08/12/2011SE |
| K091185 | 70530-BACTIAL/VIRAL Filter, 70531-HMEF, 70536-BACTERIAL/VIRAL FilterCAH · Traditional | 07/24/2009SE |
| K082009 | Hsiner Nebulizer Bottle, CPR Masks and Face ShieldsCAF · Special | 08/22/2008SE |
| K063268 | Cpap/Vpap Masks, Models 1225, 1205 and 1235BZD · Traditional | 02/23/2007SE |
| K053466 | Hsiner ResuscitatorBTM · Abbreviated | 03/22/2006SE |
| K052811 | Hsiner Jet Nebulizer, Model HS-31100CAF · Traditional | 12/21/2005SE |
Questions and answers
When was Hsiner Nebulizer Bottle cleared by the FDA?
Hsiner Nebulizer Bottle (K070948) received a 510(k) decision of Substantially Equivalent on April 25, 2007, 21 days after the submission was received.
What is the product code of K070948?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.